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Formative independent evaluation of a digital change programme in the English National Health Service: study protocol for a longitudinal qualitative study

Por: Cresswell · K. · Sheikh · A. · Dean Franklin · B. · Krasuska · M. · Nguyen · H. · Hinder · S. · Lane · W. · Mozaffar · H. · Mason · K. · Eason · S. · Potts · H. · Williams · R.
Introduction

Many countries are launching large-scale, digitally enabled change programmes as part of efforts to improve the quality, safety and efficiency of care. We have been commissioned to conduct an independent evaluation of a major national change programme, the Global Digital Exemplar (GDE) Programme, which aims to develop exemplary digital health solutions and encourage their wider adoption by creating a learning ecosystem across English National Health Service (NHS) provider organisations.

Methods and analysis

This theoretically informed, qualitative, longitudinal formative evaluation comprises five inter-related work packages. We will conduct a combination of 12 in-depth and 24 broader qualitative case studies in GDE sites exploring digital transformation, local learning and mechanisms of spread of knowledge within the Programme and across the wider NHS. Data will be collected through a combination of semistructured interviews with managers, implementation staff (clinical and non-clinical), vendors and policymakers, plus non-participant observations of meetings, site visits, workshops and documentary analysis of strategic local and national plans. Data will be analysed through inductive and deductive methods, beginning with in-depth case study sites and testing the findings against data from the wider sample and national stakeholders.

Ethics and dissemination

This work is commissioned as part of a national change programme and is therefore a service evaluation. We have ethical approval from the University of Edinburgh. Results will be disseminated at six monthly intervals to national policymakers, and made available via our publicly accessible website. We will also identify lessons for the management and evaluation of large-scale evolving digital health change programmes that are of international relevance.

Understanding the importance of non-material factors in retaining community health workers in low-income settings: a qualitative case-study in Ethiopia

Por: Arora · N. · Hanson · K. · Spicer · N. · Estifanos · A. S. · Keraga · D. W. · Welearegay · A. T. · Tela · F. G. · Hussen · Y. A. · Mandefro · Y. S. · Quaife · M.
Objectives

The motivation and retention of community health workers (CHWs) is a challenge and inadequately addressed in research and policy. We sought to identify factors influencing the retention of CHWs in Ethiopia and ways to avert their exit.

Design

A qualitative study was undertaken using in-depth interviews with the study participants. Interviews were audio-recorded, and then simultaneously translated into English and transcribed for analysis. Data were analysed in NVivo 12 using an iterative inductive-deductive approach.

Setting

The study was conducted in two districts each in the Tigray and Southern Nations, Nationalities and People’s Republic (SNNPR) regions in Ethiopia. Respondents were located in a mix of rural and urban settings.

Participants

Leavers of health extension worker (HEW) positions (n=20), active HEWs (n=16) and key informants (n=11) in the form of policymakers were interviewed.

Results

We identified several extrinsic and intrinsic motivational factors affecting the retention and labour market choices of HEWs. While financial incentives in the form of salaries and material incentives in the form of improvements to health facility infrastructure, provision of childcare were reported to be important, non-material factors like HEWs’ self-image, acceptance and validation by the community and their supervisors were found to be critical. A reduction or loss of these non-material factors proved to be the catalyst for many HEWs to leave their jobs.

Conclusion

Our study contributes new empirical evidence to the global debate on factors influencing the motivation and retention of CHWs, by being the first to include job leavers in the analysis. Our findings suggest that policy interventions that appeal to the social needs of CHWs can prove to be more acceptable and potentially cost-effective in improving their retention in the long run. This is important for government policymakers in resource constrained settings like Ethiopia that rely heavily on lay workers for primary healthcare delivery.

Stroke incidence and subtypes in Aboriginal people in remote Australia: a healthcare network population-based study

Por: Balabanski · A. H. · Goldsmith · K. · Giarola · B. · Buxton · D. · Castle · S. · McBride · K. · Brady · S. · Thrift · A. G. · Katzenellenbogen · J. · Brown · A. · Burrow · J. · Donnan · G. A. · Koblar · S. · Kleinig · T. J.
Objectives

We aimed to compare the incidence, subtypes and aetiology of stroke, and in-hospital death due to stroke, between Aboriginal and non-Aboriginal people in Central Australia, a remote region of Australia where a high proportion Aboriginal people reside (40% of the population). We hypothesised that the rates of stroke, particularly in younger adults, would be greater in the Aboriginal population, compared with the non-Aboriginal population; we aimed to elucidate causes for any identified disparities.

Design

A retrospective population-based study of patients hospitalised with stroke within a defined region from 1 January 2011 to 31 December 2014.

Setting

Alice Springs Hospital, the only neuroimaging-capable acute hospital in Central Australia, serving a network of 50 healthcare facilities covering 672 000 km2.

Participants

161 residents (63.4% Aboriginal) of the catchment area admitted to hospital with stroke.

Primary and secondary outcome measures

Rates of first-ever stroke, overall (all events) stroke and in-hospital death.

Results

Of 121 residents with first-ever stroke, 61% identified as Aboriginal. Median onset-age (54 years) was 17 years younger in Aboriginal patients (p

Conclusions

Stroke incidence (both subtypes) and in-hospital deaths for remote Aboriginal Australians are dramatically greater than in non-Aboriginal people, especially in patients aged

Exploring how people with dementia can be best supported to manage long-term conditions: a qualitative study of stakeholder perspectives

Por: Rees · J. L. · Burton · A. · Walters · K. R. · Leverton · M. · Rapaport · P. · Herat Gunaratne · R. · Beresford-Dent · J. · Cooper · C.
Objectives

To explore how the self-management of comorbid long-term conditions is experienced and negotiated by people with dementia and their carers.

Design

Secondary thematic analysis of 82 semi-structured interviews.

Setting

Community settings across the United Kingdom.

Participants

11 people with dementia, 22 family carers, 19 health professionals and 30 homecare staff.

Results

We identified three overarching themes: (1) The process of substituting self-management: stakeholders balanced the wishes of people with dementia to retain autonomy with the risks of lower adherence to medical treatments. The task of helping a person with dementia to take medication was perceived as intermediate between a personal care and a medical activity; rules about which professionals could perform this activity sometimes caused conflict. (2) Communication in the care network: family carers often communicated with services and made decisions about how to implement medical advice. In situations where family carers or homecare workers were not substituting self-management, it could be challenging for general practitioners to identify changes in self-management and decide when to intervene. (3) Impact of physical health on and from dementia: healthcare professionals acknowledged the inter-relatedness of physical health and cognition to adapt care accordingly. Some treatments prescribed for long-term conditions were perceived as unhelpful when not adapted to the context of dementia. Healthcare professionals and homecare workers sometimes felt that family carers were unable to accept that available treatments may not be helpful to people with dementia and that this sometimes led to the continuation of treatments of questionable benefit.

Conclusion

The process of substituting self-management evolves with advancement of dementia symptoms and relies on communication in the care network, while considering the impact on and from dementia to achieve holistic physical health management. Care decisions must consider people with dementia as a whole, and be based on realistic outcomes and best interests.

Acute myocardial infarction incidence and survival in Aboriginal and non-Aboriginal populations: an observational study in the Northern Territory of Australia, 1992-2014

Por: Coffey · C. · Zhao · Y. · Condon · J. R. · Li · S. · Guthridge · S.
Objectives

To examine long-term trends in acute myocardial infarction (AMI) incidence and survival among Aboriginal and non-Aboriginal people.

Design

Retrospective cohort study.

Setting, participants

All first AMI hospital cases and deaths due to ischaemic heart disease in the Northern Territory of Australia (NT), 1992–2014.

Main outcome measures

Age standardised incidence, survival and mortality.

Results

The upward trend in Aboriginal AMI incidence plateaued around 2007 for males and 2001 for females. AMI incidence decreased for non-Aboriginal population, consistent with the national trends. AMI incidence was higher and survival lower for males, for Aboriginal people and in older age groups. In 2014, the age standardised incidence was 881 and 579 per 100 000 for Aboriginal males and females, respectively, compared with 290 and 187 per 100 000 for non-Aboriginal counterparts. The incidence disparity between Aboriginal and non-Aboriginal population was much greater in younger than older age groups. Survival after an AMI improved over time, and more so for Aboriginal than non-Aboriginal patients, because of a decrease in prehospital deaths and improved survival of hospitalised cases.

Conclusions

There was an important breakpoint in increasing trends of Aboriginal AMI incidence between 2001 and 2007. The disparity in AMI survival between the NT Aboriginal and non-Aboriginal populations reduced over time as survival improved for both populations.

Effects of crowding in the emergency department on the diagnosis and management of suspected acute coronary syndrome using rapid algorithms: an observational study

Por: Stoyanov · K. M. · Biener · M. · Hund · H. · Mueller-Hennessen · M. · Vafaie · M. · Katus · H. A. · Giannitsis · E.
Objectives

Fast diagnostic algorithms using high-sensitivity troponin (hsTn) in suspected acute coronary syndrome (ACS) are regarded as beneficial to expedite diagnosis and safe discharge of patients in crowded emergency departments (ED). This study investigates the effects of crowding on process times related to the diagnostic protocol itself or other time delays, and outcomes.

Design

Prospective single-centre observational study.

Setting

ED (Germany).

Participants

Final study population of 2525 consecutive patients with suspected ACS within 12 months, after exclusion of patients with ST-elevation myocardial infarction, missing blood samples, referral from other hospitals or repeated visits.

Interventions

Use of fast algorithms as per 2015 European Society of Cardiology guidelines.

Main outcome measures

Crowding was defined as mismatch between patient numbers and monitoring capacities, or mean physician time per case, categorised as normal, high and very high crowding. Outcome measures were length of ED stay, direct discharge from ED, laboratory turn around times (TAT), utilisation of fast algorithms, absolute and relative non-laboratory time, as well as mortality.

Results

Crowding was associated with increased length of ED stay (3.75–4.89 hours, p

Conclusions

Process times, and particularly non-laboratory times, are prolonged in a crowded ED diminishing some positive effects of fast diagnostic algorithms in suspected ACS. Higher crowding levels were not significantly associated with higher all-cause mortality rates.

Trial registration number

NCT03111862.

Impact of National Drug Pricing Policy 2018 on access to medicines in Lahore division, Pakistan: a pre-post survey study using WHO/HAI methodology

Por: Saeed · A. · Saeed · H. · Saleem · Z. · Yang · C. · Jiang · M. · Zhao · M. · Ji · W. · Aziz · M. M. · Khan · F. U. · Gillani · A. H. · Atif · N. · Fang · Y. · Babar · Z. U. D.
Objective

To evaluate the impact of new National Drug Pricing Policy (NDPP) 2018 on access to medicines in terms of prices, availability and affordability.

Design

Two cross-sectional surveys were undertaken before and after the launch of NDPP 2018, using a modified WHO/Health Action International (WHO/HAI) methodology.

Setting

Four districts of Lahore division, Pakistan.

Participants

16 public sector hospitals and 16 private sector retail pharmacies.

Measures

The pre and post survey data on prices and availability of lowest price generics (LPGs) and originator brands (OBs) of 50 medicines were obtained by visiting the same public and private sector health facilities (n=32). Out of 50, 46 surveyed medicines were from the National Essential Medicines List. Inflation-adjusted median unit prices (MUPs) and median price ratios (MPRs) from 2019 were used for price comparison. Affordability was calculated in terms of number of days’ wages required to get a standard treatment by the lowest paid unskilled government worker.

Results

The overall mean percent availabilities remained poor in both years, that is, far less than 80%. In the public sector, the mean percent availability of OBs improved from 6.8% to 33.1%, whereas, in the case of LPGs, it was reduced from 35.1% to 9%. In the private sector, the mean percent availability of both OBs and LPGs demonstrated slight improvements in 2019, that is, 55.0%–58.3% and 20.3%–32.3%. The adjusted MUPs and MPRs of OBs significantly increased by a median of 4.29% (Wilcoxon test p=0.001, p=0.0001), whereas the adjusted MUPs and MPRs of LPGs increased by a median of 15.7% (p=0.002, p=0.0002). Overall, the affordability of many medicines for common ailments was reduced significantly in 2019.

Conclusions

The availability of medicines slightly improved, except in the case of LPGs, which was reduced in the public sector. The implementation of NDPP 2018 led to increase in drug prices, making the standard treatment for some of the most prevalent ailments unaffordable. So verily, the drug pricing policy must be reviewed to ensure access to essential medicines.

Development and pilot implementation of a standardised trauma documentation form to inform a national trauma registry in a low-resource setting: lessons from Tanzania

Por: Sawe · H. R. · Reynolds · T. A. · Weber · E. J. · Mfinanga · J. A. · Coats · T. J. · Wallis · L. A.
Objectives

Trauma registries are an integral part of a well-organised trauma system. Tanzania, like many low and middle-income countries, does not have a trauma registry. We describe the development, structure, implementation and impact of a context appropriate standardised trauma form based on the adaptation of the WHO Data Set for Injury (DSI), for clinical documentation and use in a national trauma registry.

Setting

Our study was conducted in emergency units of five regional referral hospitals in Tanzania.

Procedures

Mixed methods participatory action research was employed. After an assessment of baseline trauma documentation, we conducted semi-structured interviews with a purposefully selected sample of 33 healthcare providers from all participating hospitals to understand, develop, pilot and implement a standardised trauma form. We compared the number and types of variables captured before and after the form was implemented.

Outcomes

Change in proportion of variables of DSI captured after implementation of a standardised trauma documentation form.

Results

Piloting and feedback informed the development of a context appropriate standardised trauma documentation paper form with carbonless copy that could be used as both the clinical chart and data capture. Among 721 patients (seen by 21 clinicians) during the initial 30-day pilot, overall variable capture was 86.4% of required variables. After modifications of the form and training of healthcare providers, the form was implemented for 7 months, during which the capture improved to 96.3% among 6302 patients (seen by 31 clinicians). The providers reported the form was user-friendly, resulted in less time documenting, and served as a guide to managing trauma patients.

Conclusions

The development and implementation of a contextually appropriate, standardised trauma form were successful, yielding increased capture rates of injury variables. This system will facilitate expansion of the trauma registry across the country and inform similar initiatives in Sub-Saharan Africa.

Healthcare utilisation in overweight and obese children: a systematic review and meta-analysis

Por: Hasan · T. · Ainscough · T. S. · West · J. · Fraser · L. K.
Objective

This systematic review and meta-analysis aims to systematically analyse the association of overweight and obesity with health service utilisation during childhood.

Data sources

PubMed, MEDLINE, CINAHL, EMBASE and Web of Science.

Methods

Observational studies published up to May 2020 that assessed the impact of overweight and obesity on healthcare utilisation in children and adolescents were included. Studies were eligible for inclusion if the included participants were ≤19 years of age. Findings from all included studies were summarised narratively. In addition, rate ratios (RRs) and 95% CIs were calculated in a meta-analysis on a subgroup of eligible studies.

Outcome measures

Included studies reported association of weight status with healthcare utilisation measures of outpatient visits, emergency department (ED) visits, general practitioner visits, hospital admissions and hospital length of stay.

Results

Thirty-three studies were included in the review. When synthesising the findings from all studies narratively, obesity and overweight were found to be positively associated with increased healthcare utilisation in children for all the outcome measures. Six studies reported sufficient data to meta-analyse association of weight with outpatient visits. Five studies were included in a separate meta-analysis for the outcome measure of ED visits. In comparison with normal-weight children, rates of ED (RR 1.34, 95% CI 1.07 to 1.68) and outpatient visits (RR 1.11, 95% CI 1.02 to 1.20) were significantly higher in obese children. The rates of ED and outpatient visits by overweight children were only slightly higher and non-significant compared with normal-weight children.

Conclusions

Obesity in children is associated with increased healthcare utilisation. Future research should assess the impact of ethnicity and obesity-associated health conditions on increased healthcare utilisation in children with overweight and obesity.

PROSPERO registration number

CRD42018091752

Safety and efficacy of larval therapy on treating leg ulcers: a protocol for systematic review and meta-analysis

Por: Fan · W. · Yang · B. · Hu · X. · Yang · X. · Shi · C. · Liu · G.
Introduction

Leg ulcers (LUs) not only seriously affect life and work of patients, but also bring huge economic burden to the society. As a potential underused biological debridement, larval therapy provides help for the treatment of LUs. The purpose of our research is to assess whether patients with LUs can benefit from larval therapy.

Methods and analysis

The following electronic databases will be searched: PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure Database, Wanfang Database and Chinese Biological Medicine. Randomised controlled trials are eligible for inclusion. There will be no restrictions with respect to language and search date is up to June 2020. Primary outcomes investigated are complete healing rate after treatment, time to ulcer healing, reduction of wound surface area and adverse events. Risk ratios will be used for categorical data; weighted mean difference will be used for measurement data. Subgroup analysis and sensitivity analysis will be considered if heterogeneity exists. The results of data synthesis will be performed by narrative summary and quantitative analysis.

Ethics and dissemination

This systematic review does not require the approval of the ethics committee because individual data on patients are not collected. The results of the study will be disseminated in peer-reviewed journals.

PROSPERO registration number

CRD42020176953.

Protocol for Project Fizzyo, an analytic longitudinal observational cohort study of physiotherapy for children and young people with cystic fibrosis, with interrupted time-series design

Por: Raywood · E. · Douglas · H. · Kapoor · K. · Filipow · N. · Murray · N. · O'Connor · R. · Stott · L. · Saul · G. · Kuzhagaliyev · T. · Davies · G. · Liakhovich · O. · Van Schaik · T. · Furtuna · B. · Booth · J. · Shannon · H. · Bryon · M. · Main · E.
Introduction

Daily physiotherapy is believed to mitigate the progression of cystic fibrosis (CF) lung disease. However, physiotherapy airway clearance techniques (ACTs) are burdensome and the evidence guiding practice remains weak. This paper describes the protocol for Project Fizzyo, which uses innovative technology and analysis methods to remotely capture longitudinal daily data from physiotherapy treatments to measure adherence and prospectively evaluate associations with clinical outcomes.

Methods and analysis

A cohort of 145 children and young people with CF aged 6–16 years were recruited. Each participant will record their usual physiotherapy sessions daily for 16 months, using remote monitoring sensors: (1) a bespoke ACT sensor, inserted into their usual ACT device and (2) a Fitbit Alta HR activity tracker. Real-time breath pressure during ACTs, and heart rate and daily step counts (Fitbit) are synced using specific software applications. An interrupted time-series design will facilitate evaluation of ACT interventions (feedback and ACT-driven gaming). Baseline, mid and endpoint assessments of spirometry, exercise capacity and quality of life and longitudinal clinical record data will also be collected.

This large dataset will be analysed in R using big data analytics approaches. Distinct ACT and physical activity adherence profiles will be identified, using cluster analysis to define groups of individuals based on measured characteristics and any relationships to clinical profiles assessed. Changes in adherence to physiotherapy over time or in relation to ACT interventions will be quantified and evaluated in relation to clinical outcomes.

Ethics and dissemination

Ethical approval for this study (IRAS: 228625) was granted by the London-Brighton and Sussex NREC (18/LO/1038). Findings will be disseminated via peer-reviewed publications, at conferences and via CF clinical networks. The statistical code will be published in the Fizzyo GitHub repository and the dataset stored in the Great Ormond Street Hospital Digital Research Environment.

Trial registration number

ISRCTN51624752; Pre-results.

Epidemiological investigation of the first 5685 cases of SARS-CoV-2 infection in Qatar, 28 February-18 April 2020

Por: Al Kuwari · H. M. · Abdul Rahim · H. F. · Abu-Raddad · L. J. · Abou-Samra · A.-B. · Al Kanaani · Z. · Al Khal · A. · Al Kuwari · E. · Al Marri · S. · Al Masalmani · M. · Al Romaihi · H. E. · Al Thani · M. H. · Coyle · P. V. · Latif · A. N. · Owen · R. · Bertollini · R. · Butt · A. A.
Objective

To define the epidemiological curve of COVID-19 in Qatar and determine factors associated with severe or critical illness.

Design

Case series of first 5685 COVID-19 cases in Qatar.

Setting and participants

All confirmed COVID-19 cases in the State of Qatar between 28 February and 18 April 2020.

Main outcome measures

Number of total and daily new COVID-19 infections; demographic characteristics and comorbidity burden and severity of infection; factors associated with severe or critical illness.

Results

Between 28 February and 18 April 2020, 5685 cases of COVID-19 were identified. Median age was 34 (IQR 28–43) years, 88.9% were male and 8.7% were Qatari nationals. Overall, 83.6% had no concomitant comorbidity, and 3.0% had three or more comorbidities. The overwhelming majority (90.9%) were asymptomatic or with minimal symptoms, with 2.0% having severe or critical illness. Seven deaths were observed during the time interval studied. Presence of hypertension or diabetes was associated with a higher risk of severe or critical illness, but age was not. The epidemiological curve indicated two distinct patterns of infection, a larger cluster among expatriate craft and manual workers and a smaller one among Qatari nationals returning from abroad during the epidemic.

Conclusion

COVID-19 infections in Qatar started in two distinct clusters, but then became more widespread in the population through community transmission. Infections were mostly asymptomatic or with minimal symptoms and associated with very low mortality. Severe/critical illness was associated with presence of hypertension or diabetes but not with increasing age.

Job burnout and turnover intention among Chinese primary healthcare staff: the mediating effect of satisfaction

Por: Ran · L. · Chen · X. · Peng · S. · Zheng · F. · Tan · X. · Duan · R.
Objectives

Although China has done a lot in strengthening the primary healthcare system, the high turnover intention is still a social problem to be reckoned with. The objective of this study is to explore the mediating effect of satisfaction between job burnout and turnover intention.

Design

Cross-sectional study.

Methods

A cross-sectional study was conducted to make sense of the job burnout, satisfaction and turnover intention among primary healthcare workers in central China. Structural equation modelling (SEM) was performed to study the mediating effect of satisfaction between job burnout and turnover intention with maximum likelihood estimation. The mediation effect test was carried out by using the bootstrap method.

Results

SEM showed that job burnout was positively related to the turnover intention with the standard path coefficient of 0.845 (C.R.=34.055, p

Conclusions

The turnover intention is significantly affected by job burnout, satisfaction and demographical characteristics including age, education level, monthly income, hire form and night shift. Satisfaction can be regarded as a mediator between job burnout and turnover intention. Relative measures can be taken to promote enthusiasm and satisfaction thus decreasing the turnover rate.

Do components of adult height predict body composition and cardiometabolic risk in a young adult South Asian Indian population? Findings from a hospital-based cohort study in Pune, India: Pune Childrens Study

Por: Kumaran · K. · Joshi · S. M. · Di Gravio · C. · Lubree · H. · Joglekar · C. · Bhat · D. · Kinare · A. · Bavdekar · A. · Bhave · S. · Pandit · A. · Osmond · C. · Yajnik · C. · Fall · C.
Objectives

We investigated whether the relationship between components of height and cardiovascular disease (CVD) risk may be explained by body composition. We also examined relationships between parental heights and offspring CVD risk.

Design

A cohort study using cross-sectional data.

Setting

A secondary care hospital setting in Pune, India.

Participants

We studied 357 young adults and their parents in the Pune Children’s Study. Primary and secondary outcomes: we measured weight, total height, leg length, sitting height, plasma glucose, insulin and lipids, and blood pressure (BP). Total and regional lean and fat mass were measured by dual X-ray absorptiometry.

Results

Leg length was inversely related, and sitting height was directly related to BMI. Total height and leg length were directly related to lean mass, while sitting height was directly related to both lean and fat mass. Leg length was inversely related to systolic BP and 120 min glucose, independent of lean and fat mass. Sitting height was directly related to systolic BP and triglycerides; these relationships were attenuated on adjustment for lean and fat mass. When examined simultaneously, greater leg length was protective and greater sitting height was associated with a more detrimental CVD risk profile.

Conclusions

Shorter adult leg length and greater sitting height are associated with a more adverse CVD risk factor profile. The mechanisms need further study, but our findings suggest a role for lean and fat mass.

How do third sector organisations or charities providing health and well-being services in England implement patient-reported outcome measures (PROMs)? A qualitative interview study

Por: Foster · A. · O'Cathain · A. · Harris · J.
Objectives

To identify the facilitators and barriers to implementing patient-reported outcome measures (PROMs) in third sector organisations (TSOs) delivering health and well-being services.

Design

A qualitative interview study. Participants were recruited using purposive, opportunistic and snowballing methods. Framework analysis was used.

Setting

TSOs including charities, community groups and not-for-profit organisations in England, UK.

Participants

Thirty interviewees including service users, TSO front-line workers and managers, commissioners of TSOs and other stakeholders such as academic researchers.

Results

TSOs primarily used PROMs because of pressures arising from the external funding context. However, organisations often struggled to implement PROMs, rarely getting the process right first time. Facilitators for implementation included having an implementation lead committed to making it work, investing resources in data management systems and support staff and taking a collaborative approach to designing the PROMs process. The latter helped to ensure an appropriate PROMs process for the specific TSO including choosing a suitable measure and planning how data would be collected, processed and used. There was a dilemma about whether TSOs should use standardised well-being measures (eg, the Warwick-Edinburgh Mental Well-being Scale) or design their own PROM. Not all TSOs sustained the collection and reporting of PROMs over time because this required a change in organisational culture to view PROMs as beneficial for the TSO and PROMs becoming part of front-line workers’ job specifications.

Conclusions

TSOs are trying to use PROMs because they feel they have no choice but often struggle with implementation. Having an implementation lead, designing an appropriate process, investing resources, training staff and taking mitigating action to address potential barriers can facilitate implementation. Some of the findings are consistent with the experiences of more clinical services so appear relevant to the implementation of PROMs irrespective of the specific context.

Efficacy and mid/long-term survivorship of mobile-bearing unicompartmental knee arthroplasty for medial compartment knee osteoarthritis combined patellofemoral joint arthritis: a prospective cohort study protocol

Por: Cheng · J. · Feng · M. · Cao · G. · Lu · S.
Introduction

Unicompartmental knee arthroplasty (UKA) is one of the most effective surgical procedures for treating isolated medial compartment knee osteoarthritis. However, previous studies have regarded patellofemoral osteoarthritis as a contraindication for UKA. In contrast, most current research shows that damage to the articular cartilage of the patellofemoral joint, even to the extent of full-thickness cartilage loss, has no influence on the outcome of UKA.

Methods and analysis

Study settings: This study is a prospective cohort study that will compare the Forgotten Joint Score and Lonner patellofemoral joint score of patients who have undergone UKA; the patients will be divided into two groups (with and without patellofemoral joint osteoarthritis (PFJOA)). Primary objective: Long-term follow-up will be used to evaluate the effect of the operation on the above-mentioned scores in both the groups. Secondary objective: We will divide the patients from the with PFJOA group into three subgroups according to the localisation of patellofemoral cartilage lesions (medial zone, lateral zone and central zone). We aim to compare knee joint scores among these groups and clarify the impact of different wear sites on clinical efficacy. We will use CT to explore the potential mechanism through which UKA affects patellofemoral joint-related parameters (lateral patellar tilt, lateral patellar shift and tibia tuberosity-trochlear groove distance). We will also record mid-term/long-term post-surgery complications.

Ethics and dissemination

This study’s protocol is in accordance with the Declaration of Helsinki. This study was approved by the Ethics Committee of Xuanwu Hospital. The results of this study will be disseminated in international peer-reviewed journals.

Trial registration number

ChiCTR2000030310.

Evaluating spillover of HIV knowledge from study participants to their network members in a stepped-wedge behavioural intervention in Tanzania

Por: Rewley · J. · Fawzi · M. C. S. · McAdam · K. · Kaaya · S. · Liu · Y. · Todd · J. · Andrew · I. · Onnela · J. P.
Objectives

We aim to describe the social network members of participants of a behavioural intervention, and examine how the effects of the intervention may spillover among network members.

Design

Secondary analysis of a step-wedge randomised controlled trial.

Setting

Change agents (CAs) were recruited from waiting rooms of HIV treatment facilities in Dar es Salaam, Tanzania, and their network members (NMs) were recruited directly by CAs.

Participants

We enrolled 662 CAs in an HIV behavioural intervention. They, along with 710 of their NMs, completed baseline and follow-up interviews from 2011 to 2013.

Primary and secondary outcomes

The primary outcome of this study was change in NMs’ HIV knowledge, and the secondary outcome was whether the NM was lost to follow-up.

Results

At baseline, many characteristics were different between NMs and CAs. We found a number of NM characteristics significantly associated with follow-up of NMs, particularly female gender (OR=1.64, 95% CI: 1.02 to 2.63) and HIV knowledge (OR=20.0, 95% CI: 3.70 to 125); only one CA variable was significantly associated with NM follow-up: having a private source of water (OR=2.17, 95% CI: 1.33 to 3.57). The 14.2% increase in NMs’ HIV knowledge was largely due to CAs feeling empowered to pass on prior knowledge, rather than transmitting new knowledge to their NMs.

Conclusions

Characteristics of social network members of persons living with HIV persons living with HIV may play a role in study retention. Additionally, the HIV knowledge of these NMs increased largely as a function of CA participation in the intervention, suggesting that intervening among highly-connected individuals may maximise benefits to the potential population for whom spillover can occur.

Trial registration number

Clinical Trial: NCT01693458; Post-results

Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: protocol for a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery

Por: Drury · N. E. · Bi · R. · Woolley · R. L. · Stickley · J. · Morris · K. P. · Montgomerie · J. · van Doorn · C. · Dunn · W. B. · Madhani · M. · Ives · N. J. · Kirchhof · P. · Jones · T. J.
Introduction

Myocardial protection against ischaemic-reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, with current strategies, myocardial injury occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. Remote ischaemic preconditioning, the application of brief, non-lethal cycles of ischaemia and reperfusion to a distant organ or tissue, is a simple, low-risk and readily available technique which may improve myocardial protection. The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial will assess whether remote ischaemic preconditioning, applied to both lower limbs immediately prior to surgery, reduces myocardial injury in cyanotic and acyanotic young children.

Methods and analysis

The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect. Participants will be randomised in a 1:1 ratio to either bilateral remote ischaemic preconditioning (3x5 min cycles) or sham immediately prior to surgery, with follow-up until discharge from hospital or 30 days, whichever is sooner. The primary outcome is reduction in area under the time-concentration curve for high-sensitivity (hs) troponin-T release in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include peak hs-troponin-T, vasoactive inotrope score, arterial lactate and central venous oxygen saturations in the first 12 hours, and lengths of stay in the paediatric intensive care unit and the hospital.

Ethics and dissemination

The trial was approved by the West Midlands-Solihull National Health Service Research Ethics Committee (16/WM/0309) on 5 August 2016. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a local charity.

Trial registration number

ISRCTN12923441.

Strengthening integration of chronic care in Africa: protocol for the qualitative process evaluation of integrated HIV, diabetes and hypertension care in a cluster randomised controlled trial in Tanzania and Uganda

Por: Van Hout · M.-C. · Bachmann · M. · Lazarus · J. V. · Shayo · E. H. · Bukenya · D. · Picchio · C. A. · Nyirenda · M. · Mfinanga · S. G. · Birungi · J. · Okebe · J. · Jaffar · S.
Introduction

In sub-Saharan Africa, the burden of non-communicable diseases (NCDs), particularly diabetes mellitus (DM) and hypertension, has increased rapidly in recent years, although HIV infection remains a leading cause of death among young-middle-aged adults. Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV. There is an urgent need to expand healthcare capacity to provide integrated services to address these chronic conditions.

Methods and analysis

This protocol describes procedures for a qualitative process evaluation of INTE-AFRICA, a cluster randomised trial comparing integrated health service provision for HIV infection, DM and hypertension, to the current stand-alone vertical care. Interviews, focus group discussions and observations of consultations and other care processes in two clinics (in Tanzania, Uganda) will be used to explore the experiences of stakeholders. These stakeholders will include health service users, policy-makers, healthcare providers, community leaders and members, researchers, non-governmental and international organisations. The exploration will be carried out during the implementation of the project, alongside an understanding of the impact of broader structural and contextual factors.

Ethics and dissemination

Ethical approval was granted by the Liverpool School of Tropical Medicine (UK), the National Institute of Medical Research (Tanzania) and TASO Research Ethics Committee (Uganda) in 2020. The evaluation will provide the opportunity to document the implementation of integration over several timepoints (6, 12 and 18 months) and refine integrated service provision prior to scale up. This synergistic approach to evaluate, understand and respond will support service integration and inform monitoring, policy and practice development efforts to involve and educate communities in Tanzania and Uganda. It will create a model of care and a platform of good practices and lessons learnt for other countries implementing integrated and decentralised community health services.

Trial registration number

ISRCTN43896688; Pre-results.

Acupuncture for chronic cancer-related pain: a systematic review and network meta-analysis protocol

Por: Yang · J. · Xu · G. · Yin · Z. · Cheng · Y. · Sun · S. M. · Zheng · Q. · Chen · J. · Liang · F.-r. · Zhao · L.
Introduction

Chronic cancer-related pain is one of the most common excruciating symptom that can be caused by the cancer (by the primary tumour or by metastases) or by its treatment (surgery, chemotherapy and radiotherapy). Although multiple clinical trials and systematic reviews have suggested that acupuncture could be effective in treating chronic cancer-related pain, the comparative efficacy and safety of these acupuncture methods remains unclear. We, therefore, performed this study to evaluate and rank the efficacy and safety of different acupuncture methods for chronic cancer-related pain.

Methods and analysis

Seven databases will be searched, including Cochrane Library, MEDLINE, Embase, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, the Chongqing VIP Chinese Science and Technology Periodical Database and Chinese Biomedical Literature Database (CBM) from their inception to March 2020. The primary outcome is the change of pain intensity. Bayesian network meta-analysis will be conducted using software R3.5.1. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation System (GRADE) to assess the quality of evidence.

Ethics and dissemination

Ethical approval is not required for literature-based studies. The results will be disseminated through peer-reviewed publication.

PROSPERO registration number

CRD42020165747

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